FDA MedWatch - Levetiracetam Injection USP - by Sagent Pharmaceuticals:

Recall - Due to Lack of Sterility Assurance

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Levetiracetam Injection USP - by Sagent Pharmaceuticals: Recall - Due to Lack of Sterility Assurance AUDIENCE: Patient, Health Professional, Risk Manager, Neurology ISSUE: Sagent Pharmaceuticals is recalling four lots of Levetiracetam Injection, USP, which due to the lack of container closure integrity. Risk Statement: Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening.  To date, Sagent has not received reports of any product complaints or adverse events associated with this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Levetiracetam Injection is used in the treatment of certain types of seizures. RECOMMENDATIONS:  Customers that have the recalled product, have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Healthcare/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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